Oral HealthNCT05112224
A Model-based Health Education Program to Improve Oral Health in School Going Children
A study testing Education program based on health belief model to improve oral health in people with Oral Health, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
This was a randomized controlled trial to assess how an education program based on health belief model (HBM) may affect oral health status in the elementary school going children. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Education program based on health belief model to improve oral health
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIran
- Study dates
- 1 May 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 6-12 years old (elementary school going children)
- Attendance of at least one parent (either father or mother) when admission and to take part in the intervention
- Being permanent residents of the enrollment area
- Having medical record in the dental clinic
- Ability to speak and understand Persian
Who cannot join
- Children with advanced oral diseases or other critical conditions or disabilities
- Those who were using anti-inflammatory agents as a routine
- Those who had used antibiotics in past two weeks
- Children with illiterate parents
- Those on ongoing orthodontic treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Health Education Program Using Health Belief Model to Improve Oral Health in School Going Children
This was a randomized controlled trial to assess how an education program based on health belief model (HBM) may affect oral health status in the elementary school going children. For this, a convenient sample including 112 school going children aged between 6-12 years old were recruited and randomized into intervention or control groups. Education program consisted five weekly session each lasted for 1 hour approximately. Based on the main constructs of the HBM, each session was organized and a combination of educational methods were used in the intervention group while the control group only received the routine program provided by the dental clinic. Measures such as papillary bleeding index; decayed, missing, filled teeth (DMFT) and a scale based on the HBM were used for data collection. Three months after the intervention the measures were administered again and comparisons between baseline and follow-up were done.
Read the detailed description
Oral health problems especially dental carries are common in school children and education programs may help to prevent these conditions. The aim of current study was to investigate how an education program based on health belief model (HBM) may improve oral health status of the elementary school children.
One hundred twelve 6-12 year children along with one of their parents assigned into trial and control groups using a randomized controlled trial. For trial group 5 education sessions based on HBM were held, whereas control group only received routine education program delivered by the dental clinic. Decayed, missing, filled teeth (DMFT) score, papillary bleeding index, and HBM questionnaire for oral were used for evaluation of the program. Three month after the intervention reassessment was performed and the changes were measured by student t test as well as analysis of covariance test.
- Conditions
- Oral Health
- Being tested
- Education program based on health belief model to improve oral health
- Keywords
- Oral health, Gingival health, Health education, Decayed teeth
- Medical subject headings
- Health Education, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education program based on health belief model to improve oral healthBehavioural
Five weekly sessions each one lasted for one hour to encourage participants to follow healthy behaviors on oral health.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | An educational program based on HBM that was conducted using five one-hour sessions. Receives: Behavioral: Education program based on health belief model to improve oral health |
| Control | No intervention | Control group only received the education program provided by the dental clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Decayed, missing and filled teeth
Measured by decayed, missing and filled teeth (DMFT) score
Measured: Five months
Gingival health
Measured by papillary bleeding index
Measured: Five months
Constructs of health belief model
Measured by health belief model (HBM) questionnaire
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 May 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group received the intervention and another received the routine program.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Saffari, Baqiyatallah Medical Sciences University
- Investigators
- Mohsen Saffari, PhD., Study chair, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112224
- Sponsor's protocol ID
- BMSU.1395.63789
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Health Education Program Using Health Belief Model to Improve Oral Health in School Going Children
- ClinicalTrials.gov ID
- NCT05112224
- Acronym / sponsor ID
- BMSU.1395.63789
- Conditions
- Oral Health
- Keywords
- Oral health, Gingival health, Health education, Decayed teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized controlled trial to assess how an education program based on health belief model (HBM) may affect oral health status in the elementary school going children. For this, a convenient sample including 112 school going children aged between 6-12 years old were recruited and randomized into intervention or control groups. Education program consisted five weekly session each lasted for 1 hour approximately. Based on the main constructs of the HBM, each session was organized and a combination of educational methods were used in the intervention group while the control group only received the routine program provided by the dental clinic. Measures such as papillary bleeding index; decayed, missing, filled teeth (DMFT) and a scale based on the HBM were used for data collection. Three months after the intervention the measures were administered again and comparisons between baseline and follow-up were done.
Detailed description
Oral health problems especially dental carries are common in school children and education programs may help to prevent these conditions. The aim of current study was to investigate how an education program based on health belief model (HBM) may improve oral health status of the elementary school children.
One hundred twelve 6-12 year children along with one of their parents assigned into trial and control groups using a randomized controlled trial. For trial group 5 education sessions based on HBM were held, whereas control group only received routine education program delivered by the dental clinic. Decayed, missing, filled teeth (DMFT) score, papillary bleeding index, and HBM questionnaire for oral were used for evaluation of the program. Three month after the intervention reassessment was performed and the changes were measured by student t test as well as analysis of covariance test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- One group received the intervention and another received the routine program.
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: Education program based on health belief model to improve oral healthAn educational program based on HBM that was conducted using five one-hour sessions. |
| Control | No intervention | –Control group only received the education program provided by the dental clinic. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 6-12 years old (elementary school going children)
- Attendance of at least one parent (either father or mother) when admission and to take part in the intervention
- Being permanent residents of the enrollment area
- Having medical record in the dental clinic
- Ability to speak and understand Persian
Key exclusion criteria (5 listed)
- Children with advanced oral diseases or other critical conditions or disabilities
- Those who were using anti-inflammatory agents as a routine
- Those who had used antibiotics in past two weeks
- Children with illiterate parents
- Those on ongoing orthodontic treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education program based on health belief model to improve oral healthFive weekly sessions each one lasted for one hour to encourage participants to follow healthy behaviors on oral health. | Behavioural | Educational Intervention |
Primary outcome
Number of Decayed, missing and filled teeth
Time frame: Five months
Measured by decayed, missing and filled teeth (DMFT) score
Gingival health
Time frame: Five months
Measured by papillary bleeding index
Constructs of health belief model
Time frame: Five months
Measured by health belief model (HBM) questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No. No sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen Saffari, PhD. study chair
Baqiyatallah Medical Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education program based on health belief model to improve oral health in people with Oral Health, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Decayed, missing and filled teeth (time frame: Five months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.